ATGAM® Highlights

(lymphocyte immune globulin, anti-thymocyte globulin [equine])

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ATGAM safely and effectively. See full prescribing information for ATGAM.

ATGAM (lymphocyte immune globulin, anti-thymocyte globulin [equine]), sterile solution, for intravenous use only
Initial U.S. Approval: 1981

WARNING: ANAPHYLAXIS

See full prescribing information for complete boxed warning.

Anaphylaxis has been reported with the use of ATGAM. ATGAM can cause potentially life‑threatening anaphylaxis when injected intravenously. Monitor patients for signs and symptoms of anaphylaxis during infusion and for at least 24 hours after infusion [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

RECENT MAJOR CHANGES

Boxed Warning

5/2023

Dosage and Administration (2)

5/2023

Contraindications (4)

5/2023

Warnings and Precautions (5)

5/2023

INDICATIONS AND USAGE

ATGAM is an immunoglobulin G indicated for:

•
Renal allograft rejection. (1.1)
•
Aplastic anemia (moderate to severe) in patients unsuitable for bone marrow transplantation. (1.2)
•
Limitations of Use:

The usefulness of ATGAM has not been demonstrated in patients with aplastic anemia who are suitable candidates for bone marrow transplantation or in patients with aplastic anemia secondary to neoplastic disease, storage disease, myelofibrosis, Fanconi's syndrome, or in patients known to have been exposed to myelotoxic agents or radiation. (1.2)

DOSAGE AND ADMINISTRATION

For intravenous use only.

Indication

Dosage

Renal allograft rejection

10 to 15 mg/kg daily intravenously for 14 days; additional alternate-day therapy up to a total of 21 doses may be given. (2.1)

Aplastic anemia

10 to 20 mg/kg daily intravenously for 8 to 14 days; additional alternate-day therapy up to a total of 21 doses may be given. (2.1)

DOSAGE FORMS AND STRENGTHS

ATGAM 50 mg/mL concentrate for solution for infusion. (3)

CONTRAINDICATIONS

Anaphylactic reaction during prior administration of ATGAM or any other equine gamma globulin preparation. (4)

WARNINGS AND PRECAUTIONS

•
Anaphylaxis, which can be life-threatening, has been reported. To identify those at greatest risk, skin testing before treatment is strongly recommended. Discontinue ATGAM if anaphylaxis occurs. (5.1)
•
Monitor patients for signs and symptoms of cytokine release syndrome. (5.2)
•
Monitor patients for signs and symptoms of infusion-associated reactions. (5.3)
•
Monitor patients for signs and symptoms of serum sickness. (5.4)
•
Monitor and report any infection suspected to have been transmitted. (5.5)
•
Monitor patients for concurrent infection, including cytomegalovirus, Epstein-Barr virus, and herpes simplex virus infection. (5.6)
•
Do not administer live vaccines to patients about to receive, receiving, or after treatment with ATGAM due to a potential of uncontrolled viral replication in the immunosuppressed patient. (5.7)
•
Consider discontinuing therapy if severe and unremitting thrombocytopenia or neutropenia occurs. (5.8)
•
Monitor liver and renal function as clinically indicated and manage according to relevant clinical guidelines. (5.9)

ADVERSE REACTIONS

The most common (incidence >10%) adverse reactions are pyrexia, chills, rash, thrombocytopenia, leukopenia, and arthralgia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Previously masked reactions to ATGAM may appear following reduced doses of immunosuppressants. (7)

USE IN SPECIFIC POPULATIONS

•
Pregnancy: Use only if the potential benefit justifies the risk. (8.1)
•
Lactation: Discontinue breast-feeding during treatment with ATGAM or discontinue ATGAM treatment. (8.2)
•
Contraception: Advise females of reproductive potential to use effective contraception during treatment with ATGAM and for up to 10 weeks after cessation of therapy. Advise males with a female partner of reproductive potential to use effective contraception during treatment with ATGAM and for at least 10 weeks after cessation of therapy. (8.3)
•
Geriatric: Start dosing at the low end of the dosage range. (8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ATGAM safely and effectively. See full prescribing information for ATGAM.

ATGAM (lymphocyte immune globulin, anti-thymocyte globulin [equine]), sterile solution, for intravenous use only
Initial U.S. Approval: 1981

WARNING: ANAPHYLAXIS

See full prescribing information for complete boxed warning.

Anaphylaxis has been reported with the use of ATGAM. ATGAM can cause potentially life‑threatening anaphylaxis when injected intravenously. Monitor patients for signs and symptoms of anaphylaxis during infusion and for at least 24 hours after infusion [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

RECENT MAJOR CHANGES

Boxed Warning

5/2023

Dosage and Administration (2)

5/2023

Contraindications (4)

5/2023

Warnings and Precautions (5)

5/2023

INDICATIONS AND USAGE

ATGAM is an immunoglobulin G indicated for:

•
Renal allograft rejection. (1.1)
•
Aplastic anemia (moderate to severe) in patients unsuitable for bone marrow transplantation. (1.2)
•
Limitations of Use:

The usefulness of ATGAM has not been demonstrated in patients with aplastic anemia who are suitable candidates for bone marrow transplantation or in patients with aplastic anemia secondary to neoplastic disease, storage disease, myelofibrosis, Fanconi's syndrome, or in patients known to have been exposed to myelotoxic agents or radiation. (1.2)

DOSAGE AND ADMINISTRATION

For intravenous use only.

Indication

Dosage

Renal allograft rejection

10 to 15 mg/kg daily intravenously for 14 days; additional alternate-day therapy up to a total of 21 doses may be given. (2.1)

Aplastic anemia

10 to 20 mg/kg daily intravenously for 8 to 14 days; additional alternate-day therapy up to a total of 21 doses may be given. (2.1)

DOSAGE FORMS AND STRENGTHS

ATGAM 50 mg/mL concentrate for solution for infusion. (3)

CONTRAINDICATIONS

Anaphylactic reaction during prior administration of ATGAM or any other equine gamma globulin preparation. (4)

WARNINGS AND PRECAUTIONS

•
Anaphylaxis, which can be life-threatening, has been reported. To identify those at greatest risk, skin testing before treatment is strongly recommended. Discontinue ATGAM if anaphylaxis occurs. (5.1)
•
Monitor patients for signs and symptoms of cytokine release syndrome. (5.2)
•
Monitor patients for signs and symptoms of infusion-associated reactions. (5.3)
•
Monitor patients for signs and symptoms of serum sickness. (5.4)
•
Monitor and report any infection suspected to have been transmitted. (5.5)
•
Monitor patients for concurrent infection, including cytomegalovirus, Epstein-Barr virus, and herpes simplex virus infection. (5.6)
•
Do not administer live vaccines to patients about to receive, receiving, or after treatment with ATGAM due to a potential of uncontrolled viral replication in the immunosuppressed patient. (5.7)
•
Consider discontinuing therapy if severe and unremitting thrombocytopenia or neutropenia occurs. (5.8)
•
Monitor liver and renal function as clinically indicated and manage according to relevant clinical guidelines. (5.9)

ADVERSE REACTIONS

The most common (incidence >10%) adverse reactions are pyrexia, chills, rash, thrombocytopenia, leukopenia, and arthralgia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Previously masked reactions to ATGAM may appear following reduced doses of immunosuppressants. (7)

USE IN SPECIFIC POPULATIONS

•
Pregnancy: Use only if the potential benefit justifies the risk. (8.1)
•
Lactation: Discontinue breast-feeding during treatment with ATGAM or discontinue ATGAM treatment. (8.2)
•
Contraception: Advise females of reproductive potential to use effective contraception during treatment with ATGAM and for up to 10 weeks after cessation of therapy. Advise males with a female partner of reproductive potential to use effective contraception during treatment with ATGAM and for at least 10 weeks after cessation of therapy. (8.3)
•
Geriatric: Start dosing at the low end of the dosage range. (8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2023
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